Vessel access and closure assist system and method

ABSTRACT

A vessel access and closure assist system is used for accessing a vessel to perform a vascular intervention. The system facilitates the delivery of a vessel closure device onto a blood vessel for closing an opening in the wall of the blood vessel. The vessel access and closure assist system includes a procedural introducer sheath that directly couples to a vessel closure device delivery sheath such that the procedural introducer sheath does not have to be exchanged with the vessel closure device delivery sheath.

REFERENCE TO PRIORITY DOCUMENT

This application claims priority to: (1) U.S. Provisional ApplicationSer. No. 61/994,623 entitled “VESSEL ACCESS AND CLOSURE ASSIST SYSTEMAND METHOD” and filed on May 16, 2014; and (2) U.S. ProvisionalApplication Ser. No. 62/074,964 entitled “VESSEL ACCESS AND CLOSUREASSIST SYSTEM AND METHOD” and filed on Nov. 4, 2014. The provisionalapplications are incorporated by reference in their entirety andpriority to the filing dates is claimed.

BACKGROUND

Certain vascular interventions involves the insertion of a proceduralsheath through a puncture in an artery. An internal lumen of theprocedural sheath provides a passageway for the insertion of aninterventional device into the artery and to an area of treatment. In atypical procedure, the procedural sheath is inserted into the artery andan intervention is performed using the interventional device, which isinserted into the artery via the procedural sheath. At the end of theprocedure, the procedural sheath is removed from the artery andexchanged with a vessel closure device delivery sheath, which provides apassageway for delivery of a vessel closure device to the opening in theartery.

It is important to achieve hemostasis during the exchange of theprocedural sheath with the vessel closure device delivery sheath inorder to avoid a loss of blood. Unfortunately, the exchange procedureprovides an opportunity for loss of blood and also for damage to theblood vessel as the sheaths are exchanged.

In certain clinical procedures, for example procedures requiring accessto the carotid arteries, the consequences of failure to achieve completehemostasis or causing vessel injury during such an exchange procedurecan be extreme. For such transcarotid procedures, if full hemostasis isnot achieved, the resultant hematoma may lead to loss of airway passageand/or critical loss of blood to the brain, both of which lead to severepatient compromise and possibly death. Alternately, a vessel injury ordissection may require adjunct repair and lead to prolonged proceduretime and risk of complication.

SUMMARY

In view of the foregoing, there is a need for vessel access and closuresystems for more efficiently delivering a vessel closure device onto ablood vessel. Disclosed is a vessel access and closure assist system foraccessing a vessel to perform a vascular intervention, and thenfacilitating the delivery of a vessel closure device onto a blood vesselfor closing an opening in the wall of the blood vessel. The vesselaccess and closure assist system disclosed herein includes a proceduralintroducer sheath that directly couples to a vessel closure devicedelivery sheath such that the procedural introducer sheath does not haveto be exchanged with the vessel closure device delivery sheath, asdescribed in detail below.

In one aspect, a blood vessel access and closure assist system,comprising: a procedural introducer sheath sized to be inserted into anartery, the procedural introducer sheath having an internal lumen fordelivery of an interventional device into a blood vessel when theintroducer sheath is inserted into an artery; a vessel closure devicedelivery sheath, the vessel closure device delivery sheath having aninternal lumen for use with a vessel closure device applier, theinternal lumen adapted to deliver a vessel closure device onto a bloodvessel; and wherein the vessel closure device delivery sheath and theprocedural sheath fixedly couple to one another to form a singleassembly that can be inserted into an artery and wherein a distal end ofthe procedural sheath extends beyond a distal tip of the closure devicedelivery sheath when the two sheaths are coupled to one another.

In another aspect, there is disclosed A method of treating an artery,comprising: forming a sheath assembly by coupling a proceduralintroducer sheath to a vessel closure device delivery sheath, whereinthe vessel closure device delivery sheath has an internal lumen fordelivery of a vessel closure device onto a blood vessel, and wherein theprocedural introducer sheath has an internal lumen for delivery of aninterventional device into a blood vessel; inserting the sheath assemblyinto an artery such that the sheath assembly provides a passageway intothe artery; inserting an intervention device into the artery via thepassageway formed by the sheath assembly; removing the interventiondevice from the artery; uncoupling the procedural introducer sheath fromthe vessel closure device delivery sheath so that the proceduralintroducer sheath is removed from the artery while the vessel closuredevice delivery sheath remains in the artery; and using the vesselclosure device delivery sheath to deliver a vessel closure device to theartery

Other features and advantages should be apparent from the followingdescription of various embodiments, which illustrate, by way of example,the principles of the disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B show embodiments of a vessel access and closure assistsystem.

FIG. 2 shows an exemplary vessel closure device applier of a vesselaccess and closure assist system.

FIG. 3 shows an exemplary blood vessel closure device.

FIG. 4 A-D shows use of the system in accessing a vessel and thenassisting in closing the vessel using exemplary closure device.

DETAILED DESCRIPTION

Disclosed is a vessel access and closure assist system for accessing avessel to perform a vascular intervention, and then facilitating thedelivery of a vessel closure device onto a blood vessel for closing theopening in the wall of the blood vessel. The system is configured foruse with a procedural sheath that may be as long as 50 cm. It may beused to deliver a vessel closure device to a vessel access site, such asan incision, puncture, penetration or other passage through the bloodvessel.

Because most vessel closure device systems are suitable for introducersheaths 11 cm or shorter, or require special introducer sheaths, suchsystems need for a separate sheath to deliver the vessel closure device.The vessel access and closure assist system disclosed herein includes aprocedural introducer sheath that directly couples to a vessel closuredevice delivery sheath such that the procedural introducer sheath doesnot have to be exchanged with the vessel closure device delivery sheath,as described in detail below. In an embodiment, the system is packagedas a kit that includes a procedural introducer sheath, a sheath dilator,an introducer guide wire, and a vessel closure device delivery sheath.In an embodiment, the kit also includes a vessel closure device applier.In an embodiment, the vessel closure device delivery system isconfigured for use in a transcarotid procedure performed at leastpartially on a blood vessel located in the neck of a patient, such asthe carotid arteries including the common carotid artery.

FIGS. 1A and 1B shows an embodiment of a vessel access and closureassist system 1. FIG. 1A shows the system components apart from oneanother, and FIG. 1B shows the components assembled together prior touse. The system 1 includes at least a pair of sheaths including aprocedural introducer sheath 10 and a vessel closure delivery sheath 40.The two sheaths are coupled to one another to form a coupled sheathassembly that can be attached and detached as described further below.The system 1 may also include a sheath dilator 20 which is configured tofit inside the procedural sheath 10. The sheath dilator comprises adilator body and a proximal hub 25 and is configured to receive anintroducer guidewire 30. The dilator body has a tapered distal tip. Thesystem may also include the introducer guide wire 30. The proceduralsheath 10, dilator 20, and vessel closure device delivery sheath 40 areconfigured to be introduced together as a system over the introducerguide wire 30 into the artery as described more fully below.

As shown in FIG. 1A, the procedural sheath 10 comprises a sheath body 13and a proximal hub 15 that forms a coupling mechanism. In an embodimentthere is a distal radiopaque marker 12 on the distal tip of the sheathbody 13. There is a hemostasis valve 17 on the proximal end of theproximal hub 15. The hemostasis valve may be a passive seal style valve,or may be a Tuohy Borst style hemostasis valve. The hub also includes aside-arm 18 which terminates with a stopcock 19 and that defines aninternal lumen that fluidly communicates with an internal lumen of theprocedural sheath 10. Alternately, the proximal hub 15 of the proceduralsheath 10 is a female Luer connection which is configured to attach aseparate hemostasis valve component, such as a rotating hemostasis valve(RHV) or passive hemostasis valve.

The procedural sheath 10 is sized and shaped to be inserted into a bloodvessel via an access site. In this regard, the procedural sheath 10 hasan internal lumen that provides a passageway for inserting aninterventional device into the blood vessel. As mentioned, theprocedural sheath 10 may be adapted to be introduced through an incisionor puncture in a wall of a common carotid artery, either an opensurgical incision or a percutaneous puncture established, for example,using the Modified Seldinger technique or a micropuncture technique. Theworking length of the procedural sheath 10 can be in the range from 11to 50 cm, usually being from 15 cm to 25 cm. The inner diameter may bein the range from 5 Fr (1 Fr=0.33 mm), to 7 Fr, usually being 6 Fr. Theworking length is the portion of the procedural sheath that is sized andshaped to be inserted into the artery and wherein at least a portion ofthe working length is actually inserted into the artery during aprocedure.

For certain interventions, it may be desirable for the procedural sheathto have a more flexible distal section. In an embodiment, the workinglength of the procedural sheath 10 is of a length configured to accessthe proximal internal carotid artery when inserted from an accesslocation in the common carotid artery (CCA), for example 10-15 cm. Inanother embodiment the device is has a working length configured toaccess the distal cervical internal carotid artery (ICA) when insertedfrom the CCA, for example 15-25 cm. In yet another embodiment, theprocedural sheath is of a working length configured to access thepetrous, cavernous, or terminal portion of the ICA when inserted fromthe CCA, for example 20-35 cm. In this embodiment, the distal-mostportion (which may have a length of about 3 to about 6 cm) of theprocedural sheath may be configured to be more flexible to accommodatethe curvature in the petreous portion of the ICA. This additionalflexibility may be achieved by using a lower durometer outer jacketmaterial in this section. Alternately, the wall thickness of the jacketmaterial may be reduced, and/or the density of the reinforcement layermay be varied to increase the flexibility. For example the pitch of thecoil or braid may be stretched out, or the cut pattern in the tubing maybe varied to be more flexible. The distal most portion of the proceduralsheath may also be tapered or stepped down to a smaller diameter. In anembodiment, the procedural sheath may include multiple sections offlexibility, with increasing flexibility towards the distal end. U.S.patent application Ser. No. 14/569,365 filed Dec. 12, 2014 and U.S. Pat.No. 8,157,760 describe related systems and are both incorporated hereinby reference in their entirety.

The procedural sheath 10 may also include a connection to a flow line orshunt which may be connected to a device for passive or active reverseflow. In an embodiment, the flow line has an internal lumen thatcommunicates with an internal lumen of the procedural sheath 10 forshunting blood from the procedural sheath. In an embodiment, the flowline is a side arm or Y-arm that is attached to and extends from theprocedural sheath 10 at a location between the distal and proximal endsof the procedural sheath 10.

The vessel closure device delivery sheath 40 comprises an elongated body43 and a proximal hub 45 which includes a hemostasis valve 47 and an endcap 46 on the proximal region of the elongated body 43. The proximal hubforms a coupling mechanism that couples to the coupling mechanism of theprocedural sheath 10. The vessel closure device delivery sheath 40 hasan internal lumen such that it can co-axially fit over the proceduralsheath 10 and be shorter than the procedural sheath but still suitablefor use in percutaneous procedures, for example in a range between 8 to11 cm. As noted above, most vessel closure device systems are suitablefor introducer sheaths 11 cm or shorter. In an embodiment, the vesselclosure device delivery sheath 40 has a working length of 8 to 11 cm andthe procedural sheath has a minimum working length of 1 cm greater thanthe length of the vessel closure device delivery sheath 40, with a rangeof lengths as described above.

For a system 1 to be configurable for vessel closure devices which canbe deployed through standard introducer sheaths, for example, the MynxVascular Closure Device (Access Closure), the vessel closure devices canbe deployed through a vessel closure device delivery sheath 40 with astandard sheath hemostasis valve 47. In some instances, a vessel closuredevices require custom delivery sheaths, for instance, the StarClose(Abbott Vascular) and Angioseal (St. Jude Medical) require deliverysheaths with features that couple with the closure device deliverysystem. Typically, the custom delivery sheaths are packaged with theclosure delivery device and delivery system. At the end of theprocedure, the procedural sheath is required to be exchanged for thecustom delivery sheath to enable closure with the vessel closure system.For a system 1 to be configurable to these devices, the vessel closuredevice delivery sheath 40 requires corresponding features to enabledeployment of these devices.

The internal lumen of the vessel closure device delivery sheath 40 issized to receive the procedural sheath 10 such that the proceduralsheath 10 can be coupled to the vessel closure device delivery sheath 40by being positioned co-axially inside the vessel closure device deliverysheath 40. In this regard, the procedural sheath 10 is longer than theclosure device delivery sheath 40 such that procedural sheath 10 extendsout of the distal end of the vessel closure device delivery sheath 40when the two are coupled as shown in FIG. 1B. The distal tip of thevessel closure device delivery sheath 40 sheath is sized and shaped tocreate a tight fit and smooth transition between the outer diameter ofthe procedural sheath 10 and the inner diameter of the vessel closuredevice delivery sheath 40, such that the insertion of the assembledsheaths is relatively smooth and easy. In this regard, the distal tip ofthe vessel closure device delivery sheath 40 may be tapered to form agradual transition between the outer surfaces of the two sheaths.

In an embodiment, system 1 includes features which couple the vesselclosure device delivery sheath 40 and the procedural sheath 10mechanically together, such that when assembled together the sheaths maybe inserted as one, single device into the artery at the start of theprocedure such that vessel closure device delivery sheath 40 and theprocedural sheath 10 are fixed relative to one another. In one example,the procedure sheath has a rotatable collar 15 on the end of itsproximal hub with internal elements such as protrusions or threads thatcan rotationally engage and lock into grooves on the end cap 46 of thevessel closure device delivery sheath.

To assemble the two devices, the procedure sheath 10 is inserted intothe vessel closure device delivery sheath 40 until the rotating collar15 reaches and engages the end cap 46 of the vessel closure devicedelivery sheath. The collar 15 can be aligned with the end cap 46 sothat the internal elements of the collar can slide into the grooves ofthe end cap, and then rotate so that the two sheaths are now locked andfixed relative to one another. To un-couple the sheaths, the rotatingcollar 15 is rotated in the opposite direction to disengage theprotrusions or threads on the end cap 46. Alternately, the protrusionsare on the vessel closure device delivery sheath end cap 46 and thegrooves or threads are on the rotating collar. In another example, theend of the procedure sheath hub 15 has a feature which can snap into theend cap 46 of the vessel closure device delivery sheath 40 when theprocedure sheath 10 is inserted into the vessel closure device deliverysheath 40. In this example, the two sheaths are pushed together tomechanically engage one another and pulled apart to disengage from oneanother.

In another embodiment, the vessel closure device delivery sheath 40 maybe positioned anywhere that is suitable for the procedure 10 such thatthe distal tip of the procedure sheath 10 extends beyond the distal tipof the vessel closure device delivery sheath 40, up to the point wherethe closure sheath hub 45 abuts the procedure sheath hub 15 and can bemanipulated and/or used as an unit or system.

The sheath dilator 20 has an internal lumen sized to co-axially receivean introducer guidewire 30. In an embodiment, the guide wire 30 is an0.038″ outer diameter guidewire, and the dilator 20 internal lumendiameter and taper shaped are optimized to provide a smooth transitionfrom the dilator 20 to the guide wire 30. In another embodiment, theguide wire 30 is an 0.035″ diameter guidewire, with sheath dilator 20inner lumen diameter and taper configured accordingly. In anotherembodiment the guide wire 30 is an 0.018″, an 0.016″, or an 0.014″ ODguide wire, with sheath dilator 20 inner lumen diameter and taperconfigured accordingly. The guide wire 30 has an atraumatic tip 35 onthe distal end. In an embodiment, the guide wire tip 35 has a J-shape.In another embodiment, the guide wire tip 35 is an angled tip. Inanother embodiment the guide wire has a floppy tip. In an embodiment,the guide wire core is constructed from spring stainless steel. Inanother embodiment, the guide wire core is constructed from nitinol. Inanother embodiment, the guide wire core is a combination of stainlesssteel and nitinol.

FIG. 2 shows an embodiment of an exemplary vessel closure device applier105, which is configured to deliver a vessel closure device onto anartery. In an embodiment, the applier 105 is configured to deliver avessel closure device, such as the type of closure clip described inU.S. patent application Ser. No. 12/713,630 entitled Vessel Closure ClipDevice, which is incorporated herein in its entirety. An exemplaryvessel closure device 350 is shown in FIG. 3. However, the vesselclosure device delivery sheath may work with other types of vesselclosure devices and device appliers. In an embodiment, the vessel accessand closure assist system 1 includes the vessel closure device applier105. In another embodiment, the applier 105 is not part of system 1.

As shown in FIG. 2, the applier 105 includes a handle 110, which issized and shaped to be grasped by a user. An elongated delivery shaft115 extends outward from a distal end of the handle 110. At the end ofthe procedure, the procedural sheath 10 is uncoupled and removed fromthe vessel closure device delivery sheath 40. The shaft 115 of applier105 is inserted into the inner lumen of the vessel closure devicedelivery sheath 40 so as to deliver the closure device 350 to the wallof the vessel. In an embodiment, the shaft 115 passes through the sheath40 until the handle abuts the proximal hub 45 of the vessel closuredevice delivery sheath 40, at which time the hub 45 can be attached tothe handle 110.

FIG. 3 shows an exemplary vessel closure device 350 comprised of a clipfor closing an incision. It should be appreciated the clip shown in FIG.3 is an example and that other types of clips and other types of vesselclosure device may be used with the system. The clip is adapted totransition between a cylindrical configuration and a flat or planarconfiguration. The annular body may include a plurality of looped orcurved elements 310 and tines 305 that are connected to one another toform the body. Each looped element 310 may include an inner or firstcurved region 315 and an outer or second curved region 320. When theclip is in the substantially flat or planar configuration, as shown inFIG. 3, the first curved regions 315 may define an inner periphery ofthe body and the clip, and the second curved regions 320 may define anouter periphery of the body.

In an embodiment, the applier 105 is configured to deliver the vesselclosure clip 350 to the artery. The clip is deployed from applier 105,transitioning from a cylindrical configuration (as stored) to a flatconfiguration in the vessel wall (post deployment). In this embodiment,the applier includes a tubular housing 122 which contains the vesselclosure clip 350 in the cylindrical configuration and is movably coupledto the shaft 115 to deliver the vessel closure clip 350 to the surfaceof the vessel. That is, the tubular housing 122 moves along the shaft115. In this embodiment, the tubular housing 122 is larger in diameterthan the shaft 115 such that the tubular housing 122 does not fitthrough the lumen of the vessel closure device delivery sheath 40. Thus,in this embodiment, the elongated body 43 of the vessel closure devicedelivery sheath 40 is modifiable to be able to accept the applier 105 asthe tubular housing 122 is advanced distally to the distal end of theshaft 115 to deliver the vessel closure device.

In an embodiment, the tubular housing 122 splits or tears apart the body43 of the vessel closure device delivery sheath 40 as the housing 122with the closure device 350 is advanced to the distal tip of the shaft115 and the shaft 115 is in the vessel closure device delivery sheath40. In an embodiment, the applier 105 includes a sharp blade 120 on thedistal end of tubular housing 122 to assist in initiation of the splitwhen the proximal hub 45 of the vessel closure device delivery sheath 40is coupled to the handle 110 of the applier 105. In another embodiment,the elongated body 43 of the vessel closure device delivery sheath 40radially expandable such that it can stretch to accommodate insertion ofthe housing 122 into the vessel closure device delivery sheath 40 as thehousing 122 is pushed forward to the distal end of the shaft 115. Thematerials and construction for this sheath can be but is not limited tosplittable polymer such as PTFE or polyethylene, or PET, PE or customextrusion that has been pre-scored with a blade in order to produce athinner wall section to facilitate the splitting.

Another exemplary vessel closure device is a plug-type closure deviceand associated closure device applier. This type of device deposits aplug material such as a collagen plug or polymer material against theoutside of the vessel access site and typically expands in situ tocreate hemostasis at the site. Some devices additionally providetemporary, semi-permanent or permanent anchoring to ensure sufficientcompression of the plug against the access site to maintain hemostasis.In an embodiment, the applier 105 is configured to deliver a vesselclosure device, such as the type of device described in U.S. Pat. No.5,676,689. In this example, the vessel closure device delivery sheath 40is configured to be compatible with this plug device applier. Forexample, features on the device applier will mate with features on theproximal hub 47 of vessel closure device delivery sheath 40 to ensurethat the applier is in the correct orientation with respect to thesheath, The vessel closure device delivery sheath 40 may also includefeatures such as blood inlet holes to ensure that the sheath is in thecorrect position with respect to the vessel to accurately deposit theplug.

An exemplary method of using the vessel access and closure assist systemis now described, as shown in FIG. 4A-4D. An introducer guidewire 30 isinserted into the blood vessel via the access site using standardtechniques, for example a modified Seldinger or micropuncture technique.The sheath dilator 20 is inserted into the procedural sheath 10, untilthe dilator hub 25 snaps into or otherwise engages the procedural sheathhub 15.

The procedural sheath 10 is then coupled to the vessel closure devicedelivery sheath 40 by inserting the procedural sheath 10 into the vesselclosure device delivery sheath 40 such that the two are co-axiallyaligned. Alternately, the vessel closure device delivery sheath 40 isinserted into the procedural sheath 10 in another embodiment. Therotating collar 15 on the procedural sheath engages the end cap 46 onthe vessel closure device delivery sheath hub 45 and is rotated to lockthe two sheaths together such that they are immobilized relative to oneanother. When coupled, the two sheaths form a coupled sheath assemblywherein a distal end of the procedural sheath 10 extends out of and/ordistally past a distal end of the vessel closure device delivery sheath40, as shown in FIG. 1B. The coupled sheaths and dilator are theninserted into the blood vessel as a single assembly over the guide wire30 through the access site into to the blood vessel. This step is shownin FIG. 4A. Once in the blood vessel, the guide wire 30 and sheathdilator 20 are removed, leaving the two coupled sheaths as shown in FIG.4B. In this manner, the coupled sheaths (procedure sheath 10 and vesselclosure device delivery sheath 40) provide a passageway into the bloodvessel whereby hemostasis is maintained by hemostasis valves 47 and 17.As mentioned, the access site may be a transcarotid access site such asin the region of the carotid arteries.

The side arm 18 and stopcock 19 may be used to flush the internal lumenof the procedural sheath 10 as well as inject contrast as desired duringthe procedure. An interventional device (which may also referred to as aprocedural device), such as a balloon catheter, stent delivery catheter,aspiration catheter, thrombectomy catheter, or other working catheter,can then be introduced into the artery via the internal lumens of thecoupled sheaths. The devices may be used in conjunction withintermediate or distal access catheters, microcatheters, guide wires,and the like. In this regard, the internal lumen of the proceduralsheath 10 provides a passageway for insertion of interventional devices.In an example, the catheter can be used to treat the plaque such as todeploy a stent into a carotid or cerebral artery. As mentioned, a stentdelivery catheter and method is just an example of an intervention thatcan be used in conjunction with the vessel access and closure assistsystem. Other interventions are possible such as, for example,intracranial balloon angioplasty, intracranial thrombectomy, treatmentof intracerebral aneurysms, arteriovenous malformations, or otherintracerebral procedures.

At the conclusion of the intervention, the interventional device ordevices are then removed from the coupled sheath assembly. Theprocedural sheath 10 and vessel closure device delivery sheath 40 arethen uncoupled either by rotating a connector attached to sheath 10 athub 15 or by detaching a snap interface at hub 15 from the proceduralsheath 10 and pulling sheath 10 out of the vessel closure devicedelivery sheath 40. The vessel closure device delivery sheath 40 thenremains in the artery as shown in FIG. 4C. Advantageously, the vesselclosure device delivery sheath 40 is already positioned in the arterydue to the vessel closure device delivery sheath 40 and the proceduralsheath 10 being pre-coupled to one another and positioned in the arteryas a single assembly. This eliminates the step of having to perform anexchange procedure where the procedural sheath 10 is removed from theartery and then the vessel closure device delivery sheath 40 is insertedinto the artery. In certain clinical procedures, for example proceduresrequiring access to the carotid arteries, the consequences of failure toachieve complete hemostasis or causing vessel injury during such anexchange procedure can be extreme. In this instance, if full hemostasisis not achieved, the resultant hematoma may lead to loss of airwaypassage and/or critical loss of blood to the brain, both of which leadto severe patient compromise and possibly death. Alternately, a vesselinjury or dissection may require adjunct repair and lead to prolongedprocedure time and risk of complication.

With the vessel closure device delivery sheath 40 positioned in theartery, the shaft 115 (FIG. 2) of the applier 105 is then inserted intothe vessel closure device delivery sheath 40 such that the sheath hub 45is coupled to the distal end of the handle 110, as shown in FIG. 4D. Thevessel closure device delivery sheath 40 provides a passageway fordelivery of the vessel closure device such as a closure clip. Asmentioned, the tubular housing 122 (FIG. 2) can split or tear apart thebody 43 of the vessel closure device delivery sheath 40 as the closuredevice is delivered. In another embodiment, the elongated body 43 of thevessel closure device delivery sheath 40 radially expands 40 as thetubular housing 122 (FIG. 2) travels toward the closure location and theclosure device is delivered.

While this specification contains many specifics, these should not beconstrued as limitations on the scope of an invention that is claimed orof what may be claimed, but rather as descriptions of features specificto particular embodiments. Certain features that are described in thisspecification in the context of separate embodiments can also beimplemented in combination in a single embodiment. Conversely, variousfeatures that are described in the context of a single embodiment canalso be implemented in multiple embodiments separately or in anysuitable sub-combination. Moreover, although features may be describedabove as acting in certain combinations and even initially claimed assuch, one or more features from a claimed combination can in some casesbe excised from the combination, and the claimed combination may bedirected to a sub-combination or a variation of a sub-combination.Similarly, while operations are depicted in the drawings in a particularorder, this should not be understood as requiring that such operationsbe performed in the particular order shown or in sequential order, orthat all illustrated operations be performed, to achieve desirableresults.

Although embodiments of various methods and devices are described hereinin detail with reference to certain versions, it should be appreciatedthat other versions, embodiments, methods of use, and combinationsthereof are also possible. Therefore the spirit and scope of theappended claims should not be limited to the description of theembodiments contained herein.

The invention claimed is:
 1. A method of treating an artery, comprising:forming a sheath assembly by coupling a procedural introducer sheath toa vessel closure device delivery sheath, wherein the vessel closuredevice delivery sheath has an internal lumen for delivery of a vesselclosure device onto a blood vessel, and wherein the proceduralintroducer sheath has an internal lumen for delivery of aninterventional device into a blood vessel; inserting the sheath assemblyinto an artery such that the sheath assembly provides a passageway intothe artery; inserting an intervention device into the artery via thepassageway formed by the sheath assembly; removing the interventiondevice from the artery; uncoupling the procedural introducer sheath fromthe vessel closure device delivery sheath so that the proceduralintroducer sheath is removed from the artery while the vessel closuredevice delivery sheath remains in the artery; inserting at least aportion of vessel closure device applier having an elongated deliveryshaft into the internal lumen of the vessel closure device deliverysheath such that the elongated delivery shaft is positioned within theinternal lumen of the vessel closure device delivery sheath, wherein thevessel closure device applier has a sharpened housing that contains avessel closure device; advancing the sharpened housing toward a distaltip of the elongated delivery shaft of the vessel closure device applierso that the sharpened housing tears the vessel closure device deliverysheath and advanced the vessel closure device toward a distal tip of theelongated delivery shaft of the vessel closure device applier.
 2. Amethod as in claim 1, wherein coupling a procedural introducer sheath toa vessel closure device delivery sheath comprises inserting theprocedural introducer sheath into the lumen of the vessel closure devicedelivery sheath.
 3. A method as in claim 1, wherein coupling aprocedural introducer sheath to a vessel closure device delivery sheathcomprises inserting the vessel closure device delivery sheath into thelumen of the procedural introducer sheath.
 4. A method as in claim 1,further comprising immobilizing the procedural introducer sheathrelative to the vessel closure device delivery sheath.
 5. A method as inclaim 1, further comprising forming a direct puncture in a carotidartery of a patient.
 6. A method as in claim 1, wherein the artery isthe common carotid artery.
 7. A method as in claim 1, further comprisingsplitting the vessel closure device delivery sheath as the vesselclosure device is delivered to the artery.
 8. A method as in claim 1,wherein a distal end of the procedural sheath extends distally past adistal end of the vessel closure device delivery sheath when theprocedural introducer sheath is coupled to the vessel closure devicedelivery sheath.